质量管理体系 要求GB/T 19001-2016 10.2 不合格和纠正措施 10.2.1 中英文对照
质量管理体系 要求GB/T 19001-2016 10.2 不合格和纠正措施 10.2.1中英文对照
10.2 不合格和纠正措施
更新日期:2024-07-19
10.2 不合格和纠正措施 10.2.1
若出现不合格,包括来自于投诉的不合格,组织应:
- 对不合格做出应对,并在适用时:
- 采取措施以控制和纠正不合格;
- 处置所产生的后果。
- 通过下列活动,评价是否需要采取措施,以消除产生不合格的原因,避免其再次发生或者在其他场合发生:
- 评审和分析不合格;
- 确定不合格的原因;
- 确定是否存在或可能发生类似的不合格。
- 实施所需的措施;
- 评审所采取的纠正措施的有效性;
- 需要时,更新策划期间确定的风险和机遇;
- 需要时,变更质量管理体系。
纠正措施应与所产生的不合格的影响相适应。
10.2.1 10.2.1
When a nonconformity occurs, including any arising from complaints, the organization shall:
- react to the nonconformity and, as applicable:
- take action to control and correct it;
- deal with the consequences;
- evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by:
- reviewing and analysing the nonconformity;
- determining the causes of the nonconformity;
- determining if similar nonconformities exist, or could potentially occur;
- implement any action needed;
- review the effectiveness of any corrective action taken;
- update risks and opportunities determined during planning, if necessary;
- make changes to the quality management system, if necessary.
Corrective actions shall be appropriate to the effects of the nonconformities encountered.